Vietnam Circulation Number Revocation: Articles 37 and 39
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Can a circulation number be revoked in Vietnam?
A: Yes. Article 39 of Decree 98/2021 sets out the mechanism for revoking a circulation number, and the matter has been assigned to IMDA. Decree 07/2023 also renamed the relevant chapter “Revocation of device circulation numbers and handling of devices whose circulation number has been revoked“, which shows that it is a complete procedure rather than a single act.
Q: What is Article 37?
A: Article 37 sets out the mechanism for the MOH to issue a document on whether a device may continue to circulate. Its paragraph 6 (as amended by Decree 07/2023) provides that where the MOH has issued a document not permitting continued circulation, the circulation number holder or the distributing organisation is responsible for recalling devices on the market (except those already sold to healthcare institutions or users). In other words, Article 37 is the determination stage and Article 34 is the execution stage.
Q: How are devices handled after revocation?
A: Article 38 as amended by Decree 07/2023 (including the new paragraph 14) sets out the rules for handling devices whose circulation number has been revoked, matching the change to the heading of Section 5. In practice the directions are recall, correction, cessation of circulation and disposal under the statutory procedure. The applicable rule must be checked against the current text and the MOH’s case-specific requirements.
Q: What triggers revocation?
A: Typical triggers include: the device has unresolved hazardous factors (listed as an exclusion from the circulation conditions in Article 22(a)), it poses a serious threat to public health or may cause death, the application documents are untrue, and post-market obligations are not performed where the breach is serious. In addition, Article 1(4) and (5) of Decree 07/2023 expressly make “unresolved error factors that harm user health” an exclusion from the circulation conditions, linked to Article 34(4).
Q: Can a new application be made after revocation?
A: It falls within the scope of a fresh application, and a new dossier must be submitted under the current requirements, including CSDT and clinical evidence. Because revocation usually follows documentary or safety problems, the review of a new application is stricter. The more realistic approach is to complete corrective action before the revocation procedure is triggered, starting when the deficiency or corrective notice arrives rather than waiting for the revocation decision.
Practical note: treat the Article 37 document on whether continued circulation is permitted as the last warning. Once it says “not permitted”, the duty shifts from correction to recall, which is a different matter altogether. Any regulatory inquiry touching product safety should trigger the highest level of internal response, not routine correspondence.
Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Article 37 (whether continued circulation is permitted; paragraph 6 as amended by Decree 07/2023); (2) Decree No. 98/2021/NĐ-CP, Article 38 (as amended by Decree 07/2023 with the new paragraph 14) and the change of heading of Section 5; (3) Decree No. 98/2021/NĐ-CP, Article 39 (revocation of circulation numbers); (4) Decree No. 07/2023/NĐ-CP, Article 1(4), (5) and (6); (5) the MOH delegation decision assigning issuance of Article 37 documents and Article 39 revocations to IMDA.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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